Docetaxel and Gemcitabine in Hormonal Refractory Metastatic Prostate Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00115635
Recruitment Status : Completed
First Posted : June 24, 2005
Last Update Posted : October 2, 2007
Eli Lilly and Company
Information provided by:
Herlev Hospital

June 23, 2005
June 24, 2005
October 2, 2007
March 2005
Not Provided
Prostate-specific antigen (PSA) response
Same as current
Complete list of historical versions of study NCT00115635 on Archive Site
  • Clinical response
  • Time to PSA progression
  • Toxicity
Same as current
Not Provided
Not Provided
Docetaxel and Gemcitabine in Hormonal Refractory Metastatic Prostate Cancer
A Phase I/II Study With Docetaxel and Gemcitabine in Hormonal Refractory Metastatic Prostate Cancer
The aim of the study is to determine the optimal dose of the combination of docetaxel and gemcitabine in patients with hormone refractory prostate cancer, and evaluate this dose with respect to efficacy and toxicity in a phase II trial.
Not Provided
Phase 1
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Prostate Cancer
  • Drug: docetaxel
  • Drug: gemcitabine
Not Provided
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
July 2007
Not Provided

Inclusion Criteria:

  • Histologically verified adenocarcinoma of the prostate.
  • Hormone refractory prostate cancer (HRPC) defined as progression during previous anti-hormone treatment. Patients must have been off previous anti-androgen therapy for more than 4 weeks.
  • Stage IV disease (verified by imaging or clinical examination).
  • PSA > 10 microgram/l.
  • PSA progression defined as a > 25% increase between two independent measurements performed with a 1-month interval or more after discontinuation of anti-androgen treatment.
  • Castrate level of testosterone (< 50 ng).
  • No previous oestrogen or steroid as metastatic prostate cancer treatment.
  • Satisfactory hepatic function in the form of total bilirubin ≤ UNL (upper normal limit), ASAT/ALAT ≤ 2.5 x UNL, alkaline phosphatase ≤ 5 x UNL.
  • Satisfactory renal function, defined as serum creatinine ≤ 1.5 x UNL.
  • Satisfactory haematologic function defined as ANC >1.5 x 10^9/l, leucocytes >3.0 x 10^9/l, thrombocytes ≥ 100 x 10^9/l, haemoglobin > 7 mmol/l
  • ECOG performance status ≤ 2.
  • Life expectancy > 3 months.
  • Patient must be able to adhere to protocol requirements.
  • Written informed consent.
  • > 18 years of age.

Exclusion Criteria:

  • Previous prostate cancer treatment with oestrogens or steroid hormones.
  • Previous chemotherapy.
  • Previous treatment with systemic radioactive isotopes.
  • Bisphosphonate treatment (concomitant).
  • Radiation therapy covering more than 25% of the bone marrow producing area.
  • Other serious coincidental and/or concomitant medical condition.
  • Symptomatic cerebral metastases.
  • Other previous or current malignant disease, excluding *adequately treated and cured planocellular skin carcinoma; or *other cancer assessed to carry minimal risk of recurrence.
  • ECOG performance status > 2.
Sexes Eligible for Study: Male
18 Years to 95 Years   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
EudraCT number: 2004-002353-31
Not Provided
Not Provided
Not Provided
Herlev Hospital
  • Sanofi
  • Eli Lilly and Company
Principal Investigator: Lisa Sengelov, MD Dept. of Oncology, Herlev Hospital, 2730 Herlev, Denmark
Herlev Hospital
October 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP